Associate Director, Safety Scientist

AstraZeneca; Boston (MA); On-site; USD 126,000 - 190,000; Full time

Benefits offered by this job

Short-term incentives

Equity-based awards

Retirement plan

Health, dental, and vision coverage

Job summary

AstraZeneca is seeking an Associate Director, Safety Scientist to provide strategic leadership within Global Patient Safety. Based in Boston, MA, you will lead safety reviews, author safety sections in protocols and reports, and oversee safety communications with regulators, while mentoring junior scientists.

You will shape safety strategy, manage cross-functional teams, and ensure compliance with global regulations, GxP and AZ procedures, across the product lifecycle.

Qualifications

• Bachelor's degree in a biologic/medical/clinical/nursing field
• 5+ years of pharmaceutical industry drug safety/pharmacovigilance
• Subject matter expertise in global pharmacovigilance regulations and aggregate safety reports

Responsibilities

• Lead safety data reviews and analyses for products in designated therapeutic areas
• Author safety sections of clinical documents (protocols, ICFs, IBs, SAPs, CSR, DMC documents)
• Coordinate and prepare high-quality aggregate safety reports (PSUR, PBRER, PADER) for regulators
• Oversee safety for assets, implementing Safety Strategy and SST/SSaMT
• Lead safety surveillance and communication of results in cross-functional settings
• Author and manage health authority queries and contribute to REMS documents
• Develop risk management strategies with GPS Medical Directors
• Represent Global Patient Safety at regulatory inspections (MHRA, FDA, EMA)
• Mentor and manage junior safety scientists and fellows
• Support regulatory filings including eCTD modules and local labels
• Proactively drive safety governance, timelines and cross-functional engagement
• Contribute to standardized safety analytics and reporting processes
• Be a subject matter expert in clinical study teams and cross-functional meetings
• Assist process improvements and global regulatory knowledge growth

Skills

Pharmacovigilance expertise

Global regulations

Safety surveillance

Education

Bachelor's degree in biologic/medical/clinical/nursing

Tools

MedDRA coding

Power BI/Spotfire

Job description

The Associate Director, Safety Scientist plays a pivotal role within Global Patient Safety, providing strategic leadership and project management to proactively evaluate and manage safety risks in close collaboration with GPS Medical Director(s) and cross-functional team members throughout the lifecycle of assigned product(s). You will operate according to the highest ethical, quality and compliance standards as provided by global and local regulations, GxP practice and AZ procedures. You will report to the Director, Safety Scientist, GPS and be based in Boston, MA.

Responsibilities

• Leading safety data reviews and analyses for products in designated therapeutic areas
• Authoring or reviewing safety sections of clinical documents including but not limited to the clinical study protocol, informed consent form, Investigator's Brochure, statistical analysis plan, clinical study report, and data monitoring committee documents
• Coordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globally
• Ensuring the oversight of safety for assigned assets, including implementation and execution of the Safety Strategy and Management Team (SSaMT) and Safety Surveillance Team (SST)
• Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis results
• Leading the authoring and project management of health authority queries
• Maintaining accountability for the authoring, review and finalization (i.e., endorsement, sign-off) of risk management plans and contributing to REMS documents
• Assisting GPS Medical Directors in the development of risk management strategy
• Representing global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA)
• Mentoring, training and/or managing junior safety scientists and fellows
• Supporting activities related to new drug applications and other regulatory filings including authoring, reviewing and providing input to eCTD modules (2.5 and 2.7.4), core product information (i.e., CCDS), and local labels
• Assisting Global Safety Physicians in developing a strategy for safety-related regulatory activities
• Proactively managing safety documents by driving timely execution, engaging cross-functional stakeholders, and ensuring adherence to safety governance and regulatory timelines
• Supporting continuous improvement in safety analytics and reporting by contributing to the development of standardized procedures and templates
• Representing global patient safety as a subject matter expert in clinical study teams and cross-functional meetings
• Contributing to initiatives for process improvement and cross-departmental process consistency
• Maintaining a strong, up-to-date working knowledge of evolving global regulations

Qualifications and Experience

• Bachelor's degree in a biologic/medical/clinical/nursing field
• At least 5+ year experience in pharmaceutical industry in drug safety/pharmacovigilance
• Subject matter expertise in global pharmacovigilance regulations Experience preparing aggregate safety reports and conducting signal surveillance
• Experience with clinical development including risk/benefit analysis and safety assessment
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Strong scientific writing skills
• Demonstrated learning agility and ability to work independently
• Ability to apply decision-making principles to contribute to key scientific/clinical discussions
• Sound, independent judgement based on knowledge and expertise
• Ability to interact effectively with colleagues of multiple disciplines and cultures both within and outside the company on a global basis
• Understanding of the downstream regulatory, patient, business, and reputational impact of PV actions
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Nice to have

• Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD
• Expertise with clinical and safety databases
• Experience in MedDRA coding and search strategies
• Strong personal time-management and project-management skills
• Experience with data visualization tools (e.g., Power BI, Spotfire)
• Advanced project leadership with strong organizational and prioritization skills
• Experience with various roles in drug safety (e.g., case processing, operations)
• Mastery of Microsoft Word, PowerPoint and Excel

Compensation & Benefits

The annual base pay ranges from $126K to $190K. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted: 07-Oct-2026

Closing Date: 20-Oct-2026

Inclusion & Accommodations

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.

If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.